COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Dinapres». (16A01247)
Estratto determina V&A n. 28/2016 dell'11 gennaio 2016 Autorizzazione della variazione relativamente al medicinale DINAPRES. E' autorizzato il seguente grouping di Variazioni: B.I.b.2.e Modifica nella procedura di prova di un principio attivo o di materie prime, reattivi o sostanze intermedie utilizzati nel procedimento di fabbricazione del principio attivo - Altre modifiche in una procedura di prova (compresa una sostituzione o un'aggiunta) del principio attivo o di una materia prima o sostanza intermedia;
B.I.a.1.b) Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzati nel procedimento di fabbricazione di un principio attivo o modifica del fabbricante del principio attivo (compresi eventualmente i siti di controllo della qualita'), per i quali non si dispone di un certificato di conformita' alla farmacopea europea - Introduzione di un fabbricante del principio attivo avente il sostegno di un ASMF (Master File del principio attivo);
B.I.d.1.a) 4. Modifica del periodo di ripetizione della prova/periodo di stoccaggio o delle condizioni di stoccaggio del principio attivo quando non vi e' un certificato di conformita' alla farmacopea europea che copre il periodo di ripetizione della prova nel quadro del fascicolo approvato - Periodo di ripetizione della prova/periodo di stoccaggio - Estensione o introduzione di un periodo di ripetizione della prova/di stoccaggio sulla base...
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